XyloCor and SmartCella License Extroducer for XC001 Heart Gene Therapy

XyloCor Therapeutics, Inc., a clinical-stage biopharmaceutical company focusing on innovative gene therapies for cardiovascular diseases, has entered into a licensing agreement with SmartWise, a division of SmartCella Holding AB. This alliance grants XyloCor access to the Extroducer® Infusion Catheter System®, a state-of-the-art device engineered for the endovascular delivery of advanced treatments directly to the heart and other difficult-to-reach tissues. The Extroducer® system will be utilized for XyloCor’s lead gene therapy candidate, XC001 (encoberminogene rezmadenovec), in upcoming clinical trials and eventual commercial applications.

Al Gianchetti, President and CEO of XyloCor, expressed that this agreement with SmartCella reinforces XyloCor's commitment to enhancing the safety and efficiency of XC001 delivery. The catheter system is anticipated to facilitate non-surgical, catheter-based endocardial delivery, potentially improving the therapeutic outcomes for patients suffering from refractory angina. This collaboration aims to extend the benefits of XC001 to broader patient groups by possibly initiating treatment earlier in the progression of coronary artery disease.

XC001 is targeted to alleviate ischemic burden by promoting the formation of new blood vessels in the heart through the localized expression of various isoforms of vascular endothelial growth factor (VEGF). The Extroducer® catheter is envisioned to provide a less invasive, safer, and more effective means for XC001 delivery compared to traditional surgical methods.

Dr. Timothy D. Henry, an interventional cardiologist, endorsed the Extroducer® system, noting that it may enhance the efficiency of gene therapy delivery while reducing complications linked with surgical methods. Anticipation is high for the commencement of the Phase 2b trial of XC001 using this innovative catheter system in patients with refractory angina.

The previous EXACT Phase 1/2 trial showcased promising results for XC001. In this study, 42 patients with class II-IV angina underwent minimally invasive surgery for the direct administration of XC001 to the heart. The trial results indicated that XC001 was well-tolerated and led to significant clinical improvements, such as increased exercise duration and reduced angina frequency, attributable to decreased ischemic burden. PET imaging confirmed these clinical benefits. At the six-month mark post-treatment, 43% of patients reported no chest pain during ordinary activities, and 58% experienced no angina episodes at the 12-month follow-up. No serious adverse events related to the drug were observed.

In the Phase 2b trial, a randomized double-blind study will be conducted to assess the safety and efficacy of XC001 administered via the Extroducer® Delivery Catheter in patients with refractory angina.

Niklas Prager, CEO of SmartCella, highlighted the significance of this partnership with XyloCor. He emphasized that this collaboration exemplifies the synergistic potential of combining a pioneering delivery system with an innovative drug therapy, marking a substantial advancement in treatment options for refractory angina. This partnership is also a pivotal step in SmartCella's global expansion and exploration of the Extroducer’s future capabilities, aiming to extend its benefits to a wider patient population.

Under the terms of the agreement, XyloCor receives a global license to use the Extroducer® for XC001 administration. In return, SmartCella will supply the necessary catheters for clinical trials and commercial use. The agreement includes an upfront payment, milestones tied to clinical, regulatory, and commercial achievements, and royalties on sales, with the total deal value estimated at approximately USD 130 million.

XC001 is designed to foster the development of new blood vessels in the heart, circumventing diseased vessels and enhancing blood flow. This improvement could mitigate chest pain associated with refractory angina, enhancing patients' quality of life by enabling more physical activity. XC001 aims to avoid the toxicity issues seen with other gene therapies through a one-time, localized administration, which ensures higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

The Extroducer® Infusion Catheter System is a pioneering endovascular delivery device that facilitates direct-to-tissue drug delivery, addressing a crucial unmet need in the administration of novel therapies for conditions like solid tumors, genetic disorders, and tissue repair. The device was cleared by the U.S. FDA in June 2022, marking a significant milestone in its development and application.

XyloCor Therapeutics, Inc. is privately held and focused on developing best-in-class gene therapies to improve outcomes for patients with cardiovascular disease. Its primary candidate, XC001, is being investigated for use in patients with refractory angina, while a second investigational product, XC002, is in preclinical development for treating cardiac tissue damage from heart attacks.

SmartCella, based in Stockholm, Sweden, aims to combine advanced delivery platforms with cutting-edge cell and mRNA therapies to fully realize the potential of targeted treatments. The company operates through its primary business units: Smartwise, SmartCella Solutions, and ProCella.